University Of Colorado Denver

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  • The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.

    The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.
    Target Population
    Key Inclusion Criteria:

    Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18), or willing and able to provide assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures
    Aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board [IRB] or independent ethics committee [IEC])
    Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
    Currently hospitalized
    Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening
    Primary Investigator
    Gilead
    Study Director
    Sponsor
    Study Type
    Treatments and Interventions
    Clinicaltrials.gov Status
    Submitted to clinicaltrials.gov
    ClinicalTrials.gov Identifier
    NCT04292899
    Current Study Status
    Recruiting
    Current Study Phase
    Phase 3
    Clinical Trial Network Utilization
    Yes
    Accrual Target Number
    6000
    CTSA Support
    Yes
    Locations
  • This study plans to learn more about the effects of a medicine called baricitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Baricitinib is FDA-approved for the treatment of rheumatoid arthritis, an autoimmune condition. This study intends to define the impact of baricitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs.

    The study will recruit patients who have been diagnosed with COVID-19.

    Is baricitinib safe and effective intervention to imprpove clinical outcomes in patients hospitalized with COVID-19?
    Target Population
    Male or female aged 18 - 89 years at time of enrollment
    Hospitalized (or documented plan to hospitalize if patient is in the emergency department) with symptoms suggestive of COVID-19
    Illness of any duration that meets each of the following:

    Evidence of pneumonia, including radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) or clinical assessment (rales/crackles on exam)
    Requires supportive care, including non-invasive supplemental oxygen
    Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay within 7 days of enrollment
    Understands and agrees to comply with planned study procedures
    Provides informed consent signed by study patient or legally acceptable representative
    Primary Investigator
    Study Type
    Clinicaltrials.gov Status
    Submitted to clinicaltrials.gov
    ClinicalTrials.gov Identifier
    NCT04340232
    Current Study Status
    Not yet recruiting
    Current Study Phase
    Phase 2 - Phase 3
    Clinical Trial Network Utilization
    No
    Accrual Target Number
    80
    CTSA Support
    Yes
    Locations
    CCTSI
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    Using the ACT network to gain insight into COVID-19
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    COVID-19: Challenges, Opportunities and Unknowns
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    Associate Director, Health Data Compass

    Employer/Host
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